Dermatology Experts Of Texas

Summary Statement of Deficiencies D0000 An onsite recertification survey was conducted on 07/09/2026. The laboratory was found to be in compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory policies, laboratory twice annual accuracy records, and confirmed by staff interview, the laboratory failed to verify the accuracy of non- regulated histopathology (Mohs) procedures at least twice annually for one of two testing events in 2025. Findings included: 1. Review of the laboratory's "Quality Assurance Program" policy stated: "Quality Assurance Indicators ... - Comparison of Test Results: Bi-annually, two randomly chosen Mohs cases will be sent to a dermatopathologist for evaluation of slide adequacy and second opinion of results from the Mohs surgery procedure. A request will be made for consulting slides to be returned to Dermatology Experts Of Texas and accompanying reports will be filed in the Mohs laboratory as part of the quality assurance record." 2. Review of the laboratory's twice annual accuracy records for 2025 revealed only one event was performed in 2025. On 07/09/2026 at 1:36 PM, the laboratory was asked to provide documentation of a second event in 2025, and none was provided. The laboratory failed to have documentation of performing semi-annual accuracy assessments for histopathology slide interpretations in 2025. 3. During an interview on 07/09/2026 at 1:36 PM, the Mohs histotechnician after a review of records confirmed, the laboratory failed to verify the accuracy of non-regulated histopathology procedures at least twice annually for one of two testing events in 2025. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the laboratory policies, Mohs maps, and confirmed in interview, the laboratory failed to include the key on the Mohs map for the symbols indicating the marking dyes on the sections used on 21 of 21 Mohs maps randomly reviewed in 2025 and 2026. Findings included: 1. Review of the laboratory's policy titled "Policy for Frozen Sections" stated: "Procedure ... 3. The tissue is then dissected and inked accordingly, symbols for ink colors are drawn in the tissue map. It is the policy of this laboratory to use five ink colors: red, green, yellow, blue, and black. They are represented as follow on the Mohs map: [xxxx]- Red .... - Green xxxx-Yellow vvvv- Blue [xxx]- Black" 2. Random review of 21 patient Mohs maps from October 2025 and May 2026 showed symbols for the marking dyes used, but there was no key on the map to show what colors the symbols were, as listed by date of service and patient accession number: Date of service: 10/09/2025 Patient accession #: 25-0127, 25-0128, 25-0129, 25-0130, 25-0131, 25-0132 Date of service: 10/14/2025 Patient accession #: 25-0133, 25-0134, 25-0135, 25-136 [sic], 25-0137 Date of service: 05/07/2026 Patient accession #: 26-0076, 26-0077, 26-0078, 26-0079 Date of service: 05/14/2026 Patient accession #: 26-0080, 26-0081, 26-0082, 26-0083, 26-0084, 26-0085 3. During an interview on 07/09/2026 at 1:36 PM, the MOHs histotechnician after a review of records confirmed, the laboratory failed to include the key on the Mohs map for the symbols indicating the marking dyes on the sections used on 21 of 21 Mohs maps randomly reviewed in 2025 and 2026. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policy, patient test records, and confirmed in interview, the laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least 2 unique patient identifiers for 23 of 23 slides reviewed in 2024 (August through October). Findings included: 1. Review of the laboratory policy titled "Policy for lableing [sic] Slides" stated: "Each slide should be labeled with Patient's last name, first name (or initial), case accession number, stage number, section number, slide count in alphabetical order, and the date. (Example) Last name, First name 22-0001 I1A 09/01/22" The laboratory policy did NOT include labeling instructions to reliably identify patients using at least two unique patient identifiers to distinguish between specimens. 2. A review of patient slides from 2024 (August through October) revealed: 08/22/2024: 8 slides were labeled with patient last name and first initial, Mohs accession number, stage number, section number, slide count in alphabetical order, and the date. The Mohs accession numbers were as follows: 24M-0001, 24M- 0002. 09/26/2024: 7 slides were labeled with patient last name and first initial, Mohs accession number, stage number, section number, slide count in alphabetical order, and the date. The Mohs accession number was as follows: 24M-0003. 10/17/2024: 8 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- slides were labeled with patient last name and first initial, Mohs accession number, stage number, section number, slide count in alphabetical order, and the date. The Mohs accession number was as follows: 24M-0004. The laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least two unique patient identifiers. 3. During an interview on 11/07/2024 at 9:45 a.m., the Histotechnician after a review of the records, confirmed the above findings. -- 2 of 2 --